Systemic Lupus Erythematosus
Conditions
Interventions
Control group:According to the recommendations for mild to moderate systemic lupus erythematosus (SLE) proposed by the European League Against Rheumatism (EULAR) in 2019 and the 2020 Chinese Guidelin
Intervention group:Treatment with Qing Bai Chi Dan Decoction granules, acetate prednisolone tablets, and hydroxychloroquine sulfate tablets for 24 weeks.
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ?Patients who understand the entire process of the trial, voluntarily participate and sign the informed consent form; ?SLE patients who meet the classification criteria established by the American College of Rheumatology in 1997 and have mild or moderate disease activity (SLEDAI-2000 <15), according to the "Diagnosis and Treatment Guidelines for Systemic Lupus Erythematosus in China" in 2020; ?Patients who meet the TCM diagnostic criteria for Yin-deficiency and Internal Heat Syndrome: referring to the "Diagnosis and Treatment Protocol of Traditional Chinese Medicine for Yin-Yang Toxin Syndrome (Systemic Lupus Erythematosus)" in the "92 Disease TCM Clinical Pathways and TCM Treatment Plans (2017 version)" issued by the National Administration of Traditional Chinese Medicine. Symptoms include recurrent low-grade fever, night sweats, flushing of the cheeks, local dark brown rash, dryness of the mouth and throat, soreness and weakness of the waist and knees, hair loss, dry eyes or blurred vision, irregular or absent menstruation (for females), red tongue body with scanty or peeled coating, and thin or rapid pulse; ?Aged between 18 and 65 years with stable vital signs; ?Patients who have not received high-dose glucocorticoids pulse therapy within 30 days and are currently being treated with stable medium doses or below of corticosteroids (daily dose equivalent to prednisone =0.5mg/kg) and hydroxychloroquine (conventional dosage), and who have regular follow-up.
Exclusion criteria
Exclusion criteria: ?Patients who do not meet the TCM or modern medicine diagnostic criteria for SLE; ?SLE patients with severe disease activity (SLEDAI-2000 =15); ?Pediatric patients or elderly SLE patients aged over 65;?Patients who have received high-dose corticosteroid pulse therapy or cyclophosphamide pulse therapy or immunoglobulin injection therapy within 30 days, whose current treatment plans are unstable, requiring the use of medium or higher doses of corticosteroids or other immunosuppressive agents instead of hydroxychloroquine;?Patients with severe diseases affecting important organs such as the cardiovascular, cerebral, hepatic, pulmonary, renal, and hematopoietic systems, acute or chronic infectious diseases, malignant tumors, or psychiatric disorders;?Patients who are intolerant to Chinese herbal decoctions, corticosteroids, hydroxychloroquine, or those with eye diseases such as retinopathy; ?Patients with other situations that researchers deem unsuitable for inclusion in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic Lupus Erythematosus Disease Activity Index(SLEDAI-2000); | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Curative Effect;Average dosage of glucocorticoids;Incidence rate of infection events; | — |
Countries
China
Contacts
Public ContactWei-xiang Liu
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing
Outcome results
None listed